Phased probe

GUDID 06945121412360

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06945121412360
• NIH Device Record Key: 38e60039-b3ff-480d-83dc-d3712dc8b1be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phased probe
• Version Model Number: D3P64LS
• Company DUNS: 544914187
• Company Name: CHISON Medical Technologies Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945121412360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180974

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-26
• Device Publish Date: 2018-08-26

On-Brand Devices [Phased probe]

• 06945121412377: D5P64L
• 06945121412360: D3P64LS
• 06945121410274: P2-ES
• 06945121410106: P6-E
• 06945121410090: P3-E
• 06945121410083: P2-E